Recruiting

Genetic Variants

Sponsor:

Medical College of Wisconsin

Code:

NCT00710112

Conditions

Chronic Lung Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

gene variations

Study Details

Brief summary:

The purpose of this study is to determine if sequence variations in genes involved in the development and function of vulnerable organs increases susceptibility to chronic lung disease (CLD) and other diseases affecting premature infants, such as necrotizing enterocolitis (NEC), sepsis, patent ductus arteriosus (PDA) and intraventricular hemorrhage (IVH). The study will also determine whether measurement of certain biomarkers in serum will identify infants who will develop these complications of prematurity. Previous studies from this institution and others have identified genetic variants in some genes, such as toll like receptor genes are associated with higher risk of CLD or NEC. The interaction of these variants with other gene variants that can influence the risk of these diseases remains unclear.

Conditions

Chronic Lung Disease

Study ID

NCT00710112

Start date

Jun, 2006

Status verified date

Jan, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Infants born weighing less than 1500 grams

Exclusion Criteria:

  • Infants born with congenital heart disease (other than patent ductus arteriosus)
  • major congenital anomalies of the GI tract, respiratory tract, or kidneys

Study Design

Enrollment

1100 participants

Anticipated

Interventions and Outcome Measures

Arms

VLBW

infants less than 1500 grams at birth

Interventions

gene variations

comparing variations in genes in infants who develop chronic lung disease and other diseases of prematurity and those who do not.

Primary outcome measure

  • To determine if small variations in certain genes predispose infants to the development of chronic lung disease and other diseases of prematurity [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 to 8 weeks ]

Central Contacts and Locations

Central contacts

G. Ganesh Konduri, MD

414.266.6820gkonduri@mcw.edu

Kathleen M Meskin, BSN

414.337.7171kmeskin@mcw.edu

Locations

Children's Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

G. Ganesh Konduri, MD

414-266-6820gkonduri@mcw.edu

Kathleen Meskin, RN, BSN

414-337-7171kmeskin@mcw.edu

Principal Investigator:

G. Ganesh Konduri, MD

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • CLD
  • VLBW infants
  • Toll like Receptors
  • Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-01-26.